Kornimate/medical-research-clean huggingface dataset:
adolescent polycystic ovary syndrome on a low-carbohydrate diet

Conditions: Polycystic Ovary Syndrome; Adolescent Behavior; Diet Habit

Summary: the aim of the study was to investigate the changes in the clinical and biochemical parameters of adolescents on a low-carbohydrate diet in relation to their pcos phenotype in the 3rd trimester.

polycystic ovary syndrome (pcos) is an endocrine-metabolic disorder characterized by menstrual irregularities, anovulation, clinical and/or biochemical symptoms of hyperandrogenism (hirsutism and/or acne), micropolycystic ovaries, and metabolic abnormalities. in addition, some clinical and laboratory phenotypic features have been defined that were not previously included in the pcos definition criteria, but which complement the clinical picture and influence the severity and morbidity of the clinical picture. phenotype a: ha + od + pcom; phenotype b: ha + od; phenotype c: ha + pcom and phenotype d: od + pcom.for adult patients, internationally recognized diagnostic criteria have been developed based on combinations of otherwise unexplained hyperandrogenism, anovulation and polycystic ovary and are covered by the rotterdam consensus criteria. however, in the adolescent age group, the frequency of anovulatory cycles and associated menstrual irregularities, the frequent symptoms of hyperandrogenism and acne vulgaris in the developmental phase, the problems with testosterone measurement and the prevalence of polycystic ovarian morphology in normal adolescents complicate the diagnosis. pcos is a serious clinical and psychological problem for adolescent girls. key interventions include lifestyle modification, including diet, physical activity and weight loss. these measures have been shown to alter the course of the disease in overweight and obese girls. in particular, it is known that high glycemic index carbohydrate intake and glycemic load lead to a rapid rise in blood glucose levels and increased insulin production. it is therefore thought that reducing the amount of insulin could have a more positive effect on pcos than the usual carbohydrates. a low-carbohydrate diet is an effective, weight-independent approach in the treatment of metabolic disorders in pcos patients. with this in mind, this study aimed to evaluate the clinical and biochemical outcomes at month 3 after application of the low-carbohydrate diet in adolescents according to their pcos phenotype.

Eligibility criteria:
inclusion criteria: * at least 1 year has passed since menarche * under 24 years old * patients who have not received an oral contraceptive method and have given verbal and written informed consent will be included. exclusion criteria: * over 24 years old * hyperprolactinemia, cushing's syndrome, congenital adrenal hyperplasia, thyroid diseases * neuromuscular, liver, pancreatic or gastrointestinal diseases * hormonal medication such as antiandrogens, antidiabetics, glucocorticoids, insulin sensitizers or lipid regulators

Keywords: phenotype polycystic ovary syndrome adolescents low carbonhydrate diet
determining highest dose administration of tc-5214 and evaluating effect on the electrical activity in the heart

Conditions: Healthy Male

Summary: this is a two part study. part a will determine the maximum tolerated dose of tc-5214 administered to healthy male subjects in single ascending oral doses. this part of the study will define the highest dose of tc-5214 to be administered in part b. part b of this study will investigate the effect of tc-5214 on the electrical activity of the heart following single oral administration. the study will be carried out healthy male subjects in a four period crossover study with tc-5214 compared to placebo and oral moxifloxacin as a positive control. the safety, tolerability and pharmacokinetics of tc-5214 will also be evaluated.


Eligibility criteria:
inclusion criteria: * healthy male 18 to 50 years old inclusive with suitable veins for cannulation or repeated venipuncture * have a body mass index (bmi) between 19 and 30 kg/m2 inclusive and weigh at least 50 kg * male subjects should be willing to use a double barrier method of contraception (condom with spermicide) from the first dose of investigational product until 3 months after the last dose of investigational product * be able to understand and comply with the requirements of the study as judged by the investigator exclusion criteria: * history of any clinically significant medical, neurologic or psychiatric disease or disorder which, in the opinion of the investigator and sponsor may either put the subject at risk because of participation in the study, or influence the results of the subject's ability to participate in the study * history or presence of gastrointestinal (including irritable bowel disease), hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of study drug. subjects with a history of surgery on the gastrointestinal tract (not including appendectomy or cholecystectomy) should also be excluded * history of seizure activity, including febrile seizures * prolonged qtcf \>450 ms or shortened qtcf \<340 ms, or family history of long qt syndrome * use of concomitant medications that prolong qt/qtc interval

Keywords: phase i safety tolerability healthy major depressive disorder thorough qt maximum tolerated dose elimination heart electrical signal
belotecan versus topotecan for recurrent ovarian cancer: a randomized, open-label, parallel-group phase iib trial

Conditions: Epithelial Ovarian Cancer

Summary: the purpose of this study is to determine the efficacy and safety of belotecan or topotecan in patients with recurrent or refractory ovarian cancer (aoc).

a phase ⅱb, randomized, open, parallel-group, multi-center trial to assess the efficacy and safety of belotecan (camtobell inj.) or topotecan in patients with recurrent or refractory ovarian cancer

Eligibility criteria:
inclusion criteria: * at least 18 years of age * histological or cytological diagnosis of aoc * stable disease (sd) or progression at time of study entry recurrent or progressive aoc ≥ 90 days of duration of response for first-line therapy * measurable disease defined by recist criteria * ecog performance status of 0, 1, or 2 * life expectancy \> 3 months * adequate bone marrow, renal, hepatic reserve: * absolute neutrophil (segmented and bands) count (anc) ≥ 1500 cells/μl * platelet count ≥ 100,000 cells/μl * hemoglobin ≥ 9 g/dl * total bilirubin ≤ 1.5 x uln * alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤ 2.0 x uln * alkaline phosphatase (alp) ≤ 2.0 x uln * serum creatinine \ 60ml/min * signed a written informed consent exclusion criteria: * active infection * symptomatic brain lesion * any other type of cancer during the previous 5 years except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix severe concurrent diseases * prior anticancer therapy within 4 weeks before enroll * active pregnancy test and pregnant or nursing women * participation in any investigational drug study within 28 days prior to study entry

Keywords: epithelial ovarian cancer belotecan topotecan
"cognitus & moi": a new cognitive remediation tool

Conditions: Mental Retardation

Summary: holders children with intellectual disabilities have great difficulty in adapting to social situations and relationships.cognitive impairment associated with intellectual disability are important factors to understand their difficulties in processing social information. in the field of recognition of facial emotions in particular, basic cognitive processes such as visuospatial and attentional functions, are heavily involved.cognitive remediation is a management tool widely used by practitioners to help patients who experience cognitive difficulties. currently, no program can meet specific and validated the problems are children with intellectual disabilities manner in their daily functioning.

cognitus \& me is a remediation program focused on attentional functions and visuospatial, to limit the presence of behavioral disorders among children with intellectual disabilities.the main objective is to validate the effectiveness of cognitus \& me program on behavioral disorders in children with intellectual disabilities (with or without autism spectrum disorder associated).

Eligibility criteria:
inclusion criteria: * children with intellectual deficiency (5-13 years) (40 \< total iq \< 75) with or without autism spectrum disorders * native french speaker * clinically stable * parental consent exclusion criteria: * visual or auditory disorder * history of neurological illness or trauma * absence of language

Keywords: attentional disorders, intellectual deficiency
tap blockade for pain control in one-anastomosis gastric bypass

Conditions: Pain, Postoperative

Summary: patients will be randomized into 2 groups: * tap: patients undergoing tap blockade, associated with intravenous acetaminophen analgesia * iv: patients receiving only intravenous acetaminophen analgesia postoperative pain 24 hours after surgery will be evaluated.

patients will be randomized into 2 groups: * tap: patients undergoing tap blockade, associated with intravenous acetaminophen analgesia (1g/6h) * iv: patients receiving only intravenous acetaminophen analgesia (1g/6h) postoperative pain 24 hours after surgery will be evaluated, by a visual analogic scale (vas), ranging from 0 to 100mm.

Eligibility criteria:
inclusion criteria: * patients undergoing one-anastomosis gastric bypass (oagb) as primary bariatric procedure exclusion criteria: * patients undergoing oagb as revisional procedure * patients undergoing other bariatric procedures * patients undergoing additional surgical procedures during the same surgical act (band removal, cholecystectomy, hernioplasty, or hiatal hernia treatment) * patients with history of allegy to local anesthetic drugs
pharmacogenomics in prediction of cardiovascular drugs adverse reaction

Conditions: Pharmacogenetics; Drug-Related Side Effects and Adverse Reactions; Cardiovascular Drugs

Summary: the research is planned as a prospective nested case-control study. the plan is to recruit about 1,200 consecutive subjects whose pharmacotherapy involves the drug(s) of interest within 4.5 years. the basic cohort - the subjects with the newly indicated indication for use: noac; platelet aggregation inhibitors from the p2y12 receptor antagonist group; and hmg-coa reductase inhibitors (statins); as monotherapy or without restriction with respect to any other concomitant pharmacotherapy. the adrs will be analysed by cr by: age, gender, expectancy, severity, association, type (mechanism of event), and outcome, according to the classification of organ systems as well as association with the phenotype. criteria for bleeding associated with the use of anticoagulant and antiplatelet therapy have been defined; as well as the myotoxicity and hepatotoxicity associated with statin therapy. samples will be tested for biochemical, haematological, coagulation standard parameters and pharmacogenetic analyses of relevant genes depending on the used therapy. pharmacogenetic analysis will be performed to genotype the polymorphisms of relevant pharmacogenes: biological samples and clinical data will be anonymized plus all records of adrs and other clinical variables will be protected. possible drug-drug and drug-drug-gene interactions will be evaluated using the clinical decision support system (cdss) of lexicomp, pharmgkb, the flockhart table, and other systems including panel consensus methods to determine the likelihood of an adr being associated with drug interactions, and determine whether drug interactions contributed to the occurrence of adrs to administered cv pharmacotherapy in subjects with variant pharmacogenes of interest (drug-drug-gene interaction). the overall project objective is to determine which pharmacogenes variants, together with clinical parameters, can be used as predictors of cv drug adrs and are good candidates for inclusion in the clinical diagnostic panel for pre-emptive pgx testing.


Eligibility criteria:
inclusion criteria: a) age 18 years or older; b) a new indication for the administration of any of the medicinal products of primary interest (noac, clopidogrel, prasugrel, ticagrelor, statins) for which at least a 3-month administration is predicted; c) signed informed consent (for repeated evaluations and donation of blood samples for genetic and eventual pharmacokinetic analysis). exclusion criteria: the existence of contraindications to the medicines of primary interest.

Keywords: pharmacogenetics; adverse drug reactions; statins; doak; platelet aggregation inhibitors
a study for patients with non-squamous non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: chemotherapy for patients with non-squamous non-small cell lung cancer. patients are given folic acid, vitamin b12 and steroids, both before and during treatment, to reduce the side effects associated with pemetrexed. the aim is whether it is possible to simplify the folic acid and steroid schedule without increasing toxicity.


Eligibility criteria:
inclusion criteria: * histologic or cytologic diagnosis of non-small cell lung cancer (nsclc) with locally advanced or metastatic disease (stage iiia, iiib or iv)that is of non-squamous histology * patients must have failed only one prior chemotherapy regime and must be considered eligible for further chemotherapy following progression of their disease. * eastern cooperative oncology group (ecog) performance status 0 to 2 * adequate organ function exclusion criteria: * concurrent administration of any other anti-tumor therapy * other co-existing malignancies * pregnancy or breast feeding * serious concomitant disorders * inability or unwillingness to take folic acid or vitamin b12 supplementation
rapidity of response to adalimumab treatment in patients with crohn´s disease

Conditions: Moderate to Severe Crohn's Disease

Summary: the purpose of this study is to evaluate the rapidity of onset of clinical response to adalimumab therapy in patients with luminal crohn's disease.


Eligibility criteria:
inclusion criteria: * crohn's disease (cd) diagnosed within, at least, the previous 4 months. * patients with active luminal (harvey-bradshaw index \[hbi\] ≥ 8) moderate to- severe cd. * no response to a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant. * if receiving any of the following treatments, their dose should be stable during the periods indicated: * aminosalicylates for, at least, the last 4 weeks * probiotics for, at least, the last 4 weeks * analgesics for, at least, the last 4 weeks * antidiarrheals for, at least, the last 4 weeks * cd-related antibiotics for, at least, the last 4 weeks * azathioprine, 6-mercaptopurine or methotrexate for, at least, the last 12 weeks * if receiving any of the following treatments, their dose should not have been increase in the past two weeks (the dose reduction is permitted): * oral budesonide (maximum dose of 9 mg/day) * oral prednisone or equivalent (maximum dose of 40mg/day) exclusion criteria: * previous treatment with any anti-tumor necrosis factor agent * surgical bowel resection within the previous 6 months, ostomy, extensive bowel resection (\> 100 cm), short bowel syndrome * fistulising crohn's disease * treatment with cyclosporine or tacrolimus within the previous 8 weeks * clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from screening, congestive heart failure of worse than grade ii new york criteria (new york heart association functional classification). * subject with an ostomy or ileoanal pouch, proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis (subjects with a previous ileo-rectal anastomosis are not excluded). * screening laboratory values (according to central laboratory) * known hepatitis c (hc) infection. * serologic evidence of hepatitis b (hb) infection based on the results of testing for hepatitis b surface antigen (hbsag), hepatitis b core antibody (anti-hbc) and hepatitis b surface antibody (anti-hbs) antibodies.

Keywords: crohn's disease
subscapularis repair during reverse total shoulder arthroplasty

Conditions: Shoulder Osteoarthritis; Arthropathy Shoulder

Summary: this multi-site study involving northwestern medicine, beaumont health, and loyola medicine seeks to answer the following question: do patients who undergo subscapularis (ssc) repair during reverse total shoulder arthroplasty (rsa) have better post-operative outcomes than patients who do not undergo ssc repair during rsa? the investigators hypothesize that patients who do not undergo ssc repair during rsa have better post-operative outcomes than patients who undergo ssc repair during rsa. this study will address the controversy surrounding ssc repair during rsa via a multi-institutional randomized controlled trial that will compare clinical outcomes of patients who receive ssc repair during rsa to those who do not.


Eligibility criteria:
inclusion criteria: 1. primary rsa procedure with repairable (intact) ssc 2. operation will be performed by a participating surgeon using zimmer biomet comprehensive reverse shoulder system implant 3. diagnosis with imaging of arthropathy with rotator cuff insufficiency 4. surgical approach: deltopectoral 5. fluent english speakers/readers exclusion criteria: 1. minor (\<18 y/o)/vulnerable populations (pregnant women, prisoners, adults unable to consent) 2. revision surgery 3. oncologic surgery 4. non-zb crss implants 5. unrepairable ssc
identification of serum biomarkers for cd15+ hypodense neutrophils in severe asthma

Conditions: Severe Persistent Asthma

Summary: the goal of this study is to identify a serum biomarker(s) that can detect increased levels of a population of cd15+ hypodense neutrophils termed low-density granulocytes (ldg) in the blood of patients with severe persistent asthma.

neutrophils are implicated in the pathophysiology of multiple asthma phenotypes. it was shown in study ist q4935s that low-density granulocytes (ldg) are elevated in the blood of patients with moderate or severe asthma. the greatest frequency and the highest percentages of ldg were observed in subjects with severe asthma. the ldg, which were first identified and characterized in systemic lupus erythematosus (sle) patients, have been reported to display increased cytotoxicity for endothelial cells, increased tendency to form neutrophil extracellular traps, and increased production of tumor necrosis factor (tnf). it was also observed that the ldg expressed increased levels of cd15, which can facilitate attachment of activated platelets to the ldg. identification of a putative serum biomarker that correlates with increased levels of the cd15+ ldg may be useful for the detection of neutrophil-associated inflammation in severe asthma. thirty subjects will be screened to identify 20 subjects with severe persistent asthma. the following data and/or samples will then be obtained within three weeks of the clinical assessment: (1) the percentages of ldg will be quantified by flow cytometry; (2) a blood sample will be collected into a paxgene blood tube and stored until shipped to genentech for gene profiling analysis; and (3) a serum sample will be collected for measurement of total immunoglobulin e (ige) and for future confirmation of potential biomarkers identified in the gene profiling analyses.

Eligibility criteria:
inclusion criteria: * physician diagnosis of severe persistent asthma; * positive skin test or radioallergosorbent test (rast) for an aeroallergen; * male or female age 12-65 years; * non-smoker. exclusion criteria: * asthma exacerbation requiring treatment with or increase in oral corticosteroids within 30 days prior to the study; * respiratory infection within 30 days prior to the study; * starting or requiring a change in allergen immunotherapy within 30 days prior to the study; * having been treated with xolair within the past year; * requiring chronic immunosuppressive therapy; * having taken methotrexate, gold salts, cyclosporine, or macrolide antibiotics within 3 months prior to study; * having taken an investigational drug within 30 days prior to the study; * have a history of drug or alcohol abuse; * pregnancy

Keywords: asthma
citicoline in non-arteritic ischemic optic neuropathy

Conditions: Non-arteritic Ischemic Optic Neuropathy

Summary: the investigators tested the hypothesis whether the treatment with citicoline in oral solution (os-citicoline) would increase or stabilize visual acuity, retinal ganglion cells (rgcs) function and neural conduction along the visual pathways (neuroenhancement), and/or induce preservation of rgcs fibers' loss (neuroprotection) in an human model of neurodegeneration: non-arteritic ischemic optic neuropathy (naion).

the investigators enrolled 40 patients with bilateral or monolateral naion and 20 age similar controls twenty naion patients received 500 mg/day of os-citicoline for a 6-months period followed by 3-months of wash-out (19 patients completed the study, nc group); 20 naion patients were not treated (19 patients completed the studynn group) from baseline up to 9 months. in all subjects, at baseline, at 6 and 9-months of follow-up: visual acuity (va), pattern electroretinogram (perg), visual evoked potentials (vep), retinal nerve fiber layer thickness (rnfl-t) and humphrey 24-2 visual field mean deviation (hfa md) were assessed. mean differences were statistically evaluated by anova between groups, and correlations were verified by pearson's test.

Eligibility criteria:
inclusion criteria: 1. acute visual reduction episode from naion occurring for more than 6 months 2. typical defects of the visual field evidenced with the goldmann perimetry or with humphrey perimetry 30-2 3. visual acuity not less than 1/10 4. having suspended any potential neuroprotective therapies (e.g., coenzyme q10) for at least 6 months. exclusion criteria: * ocular surgery in the 3 months preceding the study, including surgery for cataracts in the previous three months. * cataract or maculopathy * known hypersensitivity to the study product * positive history for diseases of the optic nerve (retrobulbar optic neuropathy, glaucoma) or systemic diseases which could preclude the enrolment in the study according to the investigators' judgement * pregnant or nursing women, or women of potential childbearing age not using adequate contraception. * diabetes, sle, rheumatoid arthritis, mixed connective tissue disease

Keywords: citicoline non-arteritic ischemic optic neuropathy neuroprotection neuroenhancement
dose-adjusted epoch-r in myc positive dlbcl

Conditions: Diffuse Large B-cell Lymphoma

Summary: the aim of this study is to evaluate the efficacy and toxicity of dose-adjusted epoch-r in patients with myc positive diffuse large b-cell lymphoma.

the prognosis of myc positive diffuse large b-cell lymphoma (dlbcl) is very poor even treated with r-chop regimen. recently, dose-adjusted epoch-r was shown to be effective in patients with dlbcl and relapsed/refractory burkitt lymphoma. the aim of this study is to evaluate the efficacy and toxicity of dose-adjusted epoch-r in patients with myc positive diffuse large b-cell lymphoma.

Eligibility criteria:
inclusion criteria: * previously untreated myc positive diffuse large b-cell lymphoma * age range 18-70 years old * eastern cooperative oncology group performance status 0-2 * life expectancy of more than 3 months * adequate organ function exclusion criteria: * primary or secondary central nervous system involvement * previous serious cardiac disease * history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * pregnant or lactating women * serious uncontrolled diseases and intercurrent infection

Keywords: dlbcl da-epoch-r